# K112083: Lifeglobal Total, Total for Fertilization, Total W/Hepes, HTF Total, HTF Total W/Hepes - Pathway: 510(k) (Traditional) - Applicant: Intl., Inc. - Decided: May 3, 2012 after 287 days - Product code: MQL (Media, Reproductive) - Device class: 2 - Regulation: 21 CFR 884.6180 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 3 later devices descend from it; 1 cites it directly. 0 of 4 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. FDA’s file for it is a 510(k) statement, which names no predicate. ## Most influential descendants - K133707: Sage 1-Step with Human Serum Albumin, Sage 1-Step with Serum Protein Supplements (2014), 2 descendants of its own - K220715: ARTSMedia In Vitro Culture Medium (AM-IVC Medium) (2023), 0 descendants of its own - K172197: SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS (2017), 0 descendants of its own ## Indications for use LifeGlobal Global Total: Culture of human embryos from zygote to blastocyst, and embryo transfer LifeGlobal Global Total for Fertilization: Human oocyte culture and fertilization LifeGlobal Global Total w/HEPES Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer Source page: https://510kreport.com/device/K112083 Methodology: https://510kreport.com/methodology